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Found 10336 cases where Vaccine is PNC13

Case Details (Reverse Sorted by Appearance Date)

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VAERS ID:529597 (history)  Vaccinated:2014-02-21
Age:0.2  Onset:2014-02-22, Days after vaccination: 1
Gender:Female  Submitted:2014-04-28, Days after onset: 64
Location:Foreign  Entered:2014-04-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 22-FEB-2014, Blood test, no abnormalities; 22-FEB-2014, Computerised tomogram head, no abnormalities; Echocardiogram, no abnormalities; Electrocardiogram ambulatory, no abnormalities; Electroencephalogram, no abnormalities
CDC Split Type: 2014094353
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR  SCUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH13E02A SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Altered state of consciousness, Blood test normal, Computerised tomogram head normal, Crying, Cyanosis, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal, Pallor, Resuscitation
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This is a spontaneous report obtained from a contactable pediatrician through a Pfizer sales representative. A 2 month old female patient received on 21Feb2014 PREVENAR 13 (Lot #: 13E02A) subcutaneously at 0.5ml single, ACT-HIB subcutaneously at 0.5 mL, single and BIMMUGEN, which was administered at 0.25 mL, single. The patient medical history and concomitant medications were not reported. Around 19:30 on 22Feb2014: consciousness disturbed, facial pallor and cyanosis on lip developed after crying hard. Artificial respiration and chest compression were provided by the patient''s parents, and an ambulance was called. The patient presented with spontaneous breathing and crying when she arrived at the hospital. At this time nothing abnormal detected. There was no abnormality with head CT, blood test, ultrasound cardiography, Holter electrocardiogram and electroencephalogram. The event resolved on 22Feb2014 (not 26Mar2014). On 27Feb2014 the patient was discharged from the hospital. PREVENAR 13 was readministered thereafter, but recurrence of the event was not confirmed. Tests to identify the event as an adverse reaction to PREVENAR 13 were not performed. On 02Apr2014, the patient received DPT-IPV. The pediatrician assesses the event as possibly related to ACT-HIB and BIMMUGEN as well as PREVENAR 13 and commented; the causal relationship between the event and PREVENAR 13 was assessed as low, because the second injection of PREVENAR 13 was given afterward but no adverse reaction developed that time. Follow-up (21Apr2014): New information from the same contactable pediatrician through a Pfizer sales representative includes: patient''s gender, vaccines dose, clinical course, event term changed from cyanosis to consciousness disturbed, clinical course, recovery date, reporter''s assessment and comment. Follow-up attempts completed. No further information expected.

VAERS ID:529725 (history)  Vaccinated:2014-01-08
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2014-04-29
Location:Foreign  Entered:2014-04-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood culture no growth, 26Feb2014, sterile; Blood culture no growth, 10Mar2014, sterile; Blood culture no growth, 24Mar2014, sterile; Campylobacter like organism te, 24Mar2014, EIA: negative; Campylobacter test positive, 26Feb2014, EIA: positive; Campylobacter test positive, 10Mar2014, EIA: positive; Hemoglobin, Feb2014, 12.4g/dl; Polymerase chain reaction, Feb2014, positive for Rot; Polymerase chain reaction, 26Feb2014, negative for EHE; Polymerase chain reaction, 10Mar2014, negative for EHE; Polymerase chain reaction, 24Mar2014, negative for EHE; Rotavirus test, 10Mar2014, EIA: negative; Rotavirus test, 24Mar2014, EIA: negative; Rotavirus test positive, 26Feb2014, EIA: positive
CDC Split Type: D0083037A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB876A0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH073400IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA900AB0PO 
Administered by: Other     Purchased by: Other
Symptoms: Bacterial test negative, Blood culture negative, Campylobacter test positive, Diarrhoea, Escherichia test negative, Faeces discoloured, Frequent bowel movements, Haematochezia, Haemoglobin normal, Polymerase chain reaction, Rotavirus test positive, Yersinia test negative
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician and described the occurrence of blood in stools in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date in mid February 2014 the subject received an unspecified dose of ROTARIX (1.5 ml, oral). Within two weeks post vaccination with ROTARIX, on 25 February 2014, the subject experienced blood in stools. Stool was positive for rotavirus. This case was assessed as medically serious by GSK criteria. At the time of reporting, on 27 February 2014, the outcome of the events was unspecified. Follow-up information was received on 22 April 2014 from the reporting physician. The subject has no underlying or concurrent medical conditions or other risk factors. Concomitant medications included vitamin D for rachitis prophylaxis. Concomitant vaccinations included the first dose of INFANRIX HEXA (GlaxoSmithKline) and the first dose of (non-GSK) PREVENAR 13 (Pfizer Pharma), given on 08 January 2014. On 08 January 2014 the subject received the first dose of ROTARIX (1.5 ml, oral) in combination with INFANRIX HEXA (0.5 ml, intramuscular, left thigh) and PREVENAR 13 (0.5 ml, intramuscular, right thigh). Approximately 49 days post vaccination with ROTARIX, on 26 February 2014, the subject experienced stool positive for rotavirus and Campylobacter sp. Stool examinations, performed on 26 February 2014, showed enzyme immunosorbent assay (EIA) positive for rotavirus, enzyme immunosorbent assay (EIA) positive for Campylobacter sp., stool cultures negative for Campylobacter sp., enteropathogenic E. coli, Salmonella, Shigella and Yersinia and polymerase chain reaction (PCR) negative for enterohemorrhagic E. coli (EHEC)-Shiga-toxin. Stool examinations, performed on 10 March 2014, showed enzyme immunosorbent assay (EIA) negative for rotavirus, enzyme immunosorbent assay (EIA) positive for Campylobacter sp., stool cultures negative for Campylobacter sp., enteropathogenic E. coli, Salmonella, Shigella and Yersinia and polymerase chain reaction (PCR) negative for enterohemorrhagic E. coli (EHEC)-Shiga-toxin. The subject received no treatment for the events. Stool positive for rotavirus was resolved after about 14 days on 10 March 2014. Stool positive for Campylobacter sp. was resolved after about 27 days on 24 March 2014. The reporting physician considered that stool positive for rotavirus was unlikely to possibly related to vaccination with ROTARIX. The reporting physician considered that stool positive for Campylobacter sp. was unrelated to vaccination with ROTARIX. At the time of reporting, on 26 March 2014, the subject showed slight green discoloration of stools but no longer any detectable pathogens in stools. The reporting physician also provided the answers to a GSK targeted questionnaire for rotavirus infection (lack of efficacy) post vaccination with ROTARIX: The genotype or serotype of rotavirus has not been determined. Rotavirus has been confirmed by polymerase chain reaction (PCR) of a stool sample. The events were reported as follows: Approximately three weeks post vaccination with ROTARIX, on an unspecified date at end of January 2014 or early in February 2014, the subject experienced increased frequency of loose stools. At first loose stools were yellow. Later on loose stools were green and contained blood. The subject experienced about 6-9 episodes of loose stools daily. The subject received no treatment for the events. At the time of reporting, on 26 March 2014, the events were resolved. For diagnostics please see results of stool examination performed on 26 February 2014, on 10 March 2014 and on 24 March 2014 (see above). Stool examination was positive for rotavirus on 26 February 2014 and negative on 10 March 2014. Stool examination was positive for Campylobacter sp. on 26 February 2014 and 10 March 2014 and negative on 24 March 2014. Other pathogens (e.g. Norovirus, Salmonella, Escherichia coli, parasites or other infective agents) were not found. Furth

VAERS ID:529523 (history)  Vaccinated:2014-01-28
Age:0.2  Onset:2014-03-04, Days after vaccination: 35
Gender:Male  Submitted:2014-04-28, Days after onset: 54
Location:Unknown  Entered:2014-04-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Blood work and ultrasound
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURERA20CB081A0IMLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC254AC1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG167220IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA827AB0PO 
Administered by: Public     Purchased by: Public
Symptoms: Blood test, Crying, Injection site erythema, Injection site swelling, Injection site warmth, Pain, Ultrasound scan
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Cried alot with pain then both legs turn red, swollen and hot to touch. Lasts for 25-30 minutes. Cried whole time and became everything normal after 30 minutes.

VAERS ID:529530 (history)  Vaccinated:2014-01-07
Age:0.5  Onset:2014-01-07, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Florida  Entered:2014-04-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cradle cap
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4452AA1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG392911IMLL
Administered by: Public     Purchased by: Public
Symptoms: Muscle twitching, Staring
SMQs:, Dyskinesia (broad), Dystonia (broad)
Write-up: Per patient''s mom 3-5 days after receiving PCV13, DTaP patient would have staring episodes with muscle twitching. This would occur 2x per day for 3 days.

VAERS ID:529532 (history)  Vaccinated:2014-02-17
Age:0.5  Onset:2014-02-17, Days after vaccination: 0
Gender:Male  Submitted:2014-04-21, Days after onset: 62
Location:Florida  Entered:2014-04-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUI003AB1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH419481IMLL
Administered by: Private     Purchased by: Private
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Patient''s mom stated that patient cried for "hours on end" after received Hib and PCV13.

VAERS ID:529533 (history)  Vaccinated:2014-04-21
Age:0.2  Onset:2014-04-21, Days after vaccination: 0
Gender:Female  Submitted:2014-04-22, Days after onset: 1
Location:New York  Entered:2014-04-28, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS4M76D0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH967AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH000040IMLL
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Emotional distress, Irritability
SMQs:, Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Pt had 1st set of shots around 1030 on 4-21-14, 1 hr after shots started with 101 and up then became very fussy, could not console her all day. Doing better today, still has sl. temp.

VAERS ID:529534 (history)  Vaccinated:2014-04-08
Age:0.6  Onset:2014-04-09, Days after vaccination: 1
Gender:Male  Submitted:2014-04-21, Days after onset: 12
Location:Florida  Entered:2014-04-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4587AA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH972AB1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURJ17271IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH014281IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J0083851PO 
Administered by: Private     Purchased by: Public
Symptoms: Crying, Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Woke up with fever 10:30AM 4-9-14 100.4. Was irritable 4-9-14. Patient cried for 1 hour non stop.

VAERS ID:529547 (history)  Vaccinated:2014-04-23
Age:0.4  Onset:2014-04-24, Days after vaccination: 1
Gender:Male  Submitted:2014-04-28, Days after onset: 4
Location:Georgia  Entered:2014-04-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS93HY50IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURJ0119630IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURJ172710IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG410250IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J0038130PO 
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Respiratory rate increased
SMQs:, Neuroleptic malignant syndrome (broad)
Write-up: Parent state that at 3a patient had temp of 105, parent was giving patient Tylenol which would lower temps but never lower than 101. Parent also stated that patient was breathing fast. Patient presented to the clinic with a rectal temp of 103.1 and RR of 64. Patient was given rectal Tylenol 80mg and was cooled with ice packs. Patient temp came down to 99.3 and RR 54. Patient remained afebrile thereafter.

VAERS ID:529552 (history)  Vaccinated:2014-04-28
Age:1.1  Onset:2014-04-28, Days after vaccination: 0
Gender:Male  Submitted:2014-04-28, Days after onset: 0
Location:Maryland  Entered:2014-04-28
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flovent 44 mcg HFA
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.J0050100IMRL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.K0024830IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH139943IMRL
Administered by: Unknown     Purchased by: Public
Symptoms: Blood lead, Full blood count, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Received MMRV#1, Hep A#1, and PCV13#4 vaccines in right leg. Had bloodwork drawn for CBC and lead and then noted to have urticarial lesions all over body.

VAERS ID:529606 (history)  Vaccinated:2014-04-24
Age:1.1  Onset:2014-04-24, Days after vaccination: 0
Gender:Male  Submitted:2014-04-25, Days after onset: 1
Location:North Carolina  Entered:2014-04-28, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSF37NC3IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.J0111122IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.J0030040SCLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG989153IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0061070SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling at injection site. (R) thigh measures 10cm at injection site. (L) upper thigh measures 20 cm at injection site. (L) lower thigh measures 15 cm at injection site.

VAERS ID:529631 (history)  Vaccinated:2014-04-14
Age:1.0  Onset:2014-04-24, Days after vaccination: 10
Gender:Female  Submitted:2014-04-28, Days after onset: 4
Location:Washington  Entered:2014-04-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUH968AA4IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.J0057280UNRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH056474IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0081700UNLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site induration, Injection site reaction, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Red firm rash on leg. Varicella was administered x4 days. Red pinpoint rash on torso last wk, that has since resolved.

VAERS ID:529635 (history)  Vaccinated:2013-09-25
Age:44.0  Onset:2013-09-25, Days after vaccination: 0
Gender:Male  Submitted:2014-03-03, Days after onset: 159
Location:Texas  Entered:2014-04-28, Days after submission: 55
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: HIV; chronic hepatitis C; back pain
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDR52907 UNLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH006721UNRA
Administered by: Other     Purchased by: Other
Symptoms: Erythema multiforme, Pain, Rash, Swelling
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Pt experienced rash and swelling for approx 1 weeks post injection; rash from should to elbow. Stated had pain for about 1 1/2 months after injection.

VAERS ID:529573 (history)  Vaccinated:2014-04-02
Age:0.1  Onset:2014-04-03, Days after vaccination: 1
Gender:Male  Submitted:2014-04-26, Days after onset: 23
Location:Foreign  Entered:2014-04-28, Days after submission: 2
Life Threatening? No
Died? Yes
   Date died: 2014-04-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0988644A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERJ41720UNUN
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEUR 0UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER3C29010UNUN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURERV80910PO 
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH469820UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA812AC0PO 
Administered by: Other     Purchased by: Other
Symptoms: Crying, Death, Death neonatal, Diet refusal
SMQs:, Acute central respiratory depression (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of death unspecified in a 6-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), (non-gsk) OPV, (non-gsk) PENTAXIM, HepB (non-gsk), pneumococcal vaccine (non-gsk) and DTaP (non-gsk). The subject had no history of being unwell before or after immunization. On 2 April 2014, the subject received 1st dose of ROTARIX (oral), 1st dose of OPV (Non-GSK) (oral), 1st dose of PENTAXIM (unknown), 1st dose of HepB (Non-GSK) (unknown), 1st dose of Pneumococcal vaccine (Non-GSK) (unknown) and 1st dose of DTaP (Non-GSK) (unknown). On 3 April 2014, around 1 am, 1 day after vaccination with DTaP (Non-GSK), HepB (Non-GSK), OPV (Non-GSK), PENTAXIM, Pneumococcal vaccine (Non-GSK) and ROTARIX, the subject cried uncontrollably for a long period. He refused to feed and after some time, their parents put him to sleep. In the morning, the subject was found dead from an unknown cause of death. An autopsy was not performed, the subject was buried in the afternoon of 3 April 2014. The facility "Domestic" fridge was not functional therefore the vaccines were stored at Clinic and on the immunization day, the vaccines were transported in a cooler box. No possibility of mixing vaccines with other drugs since the cooler box was only used for vaccines. The cold chain on storage of vaccines was maintained. No other adverse events following immunisation had been reported at the clinic or surrounding clinics. Therefore, regulatory authority indicated that the vaccines will not be tested and were deemed safe due to the monitoring and controlling system in the county. No death certificate was available and the post mortem was refused indicating the exact cause of death. It was noted that there was no evidence that death of the baby was due to immunization. As no additional information could be obtained, the case has been closed.

VAERS ID:529457 (history)  Vaccinated:2014-04-25
Age:0.2  Onset:2014-04-25, Days after vaccination: 0
Gender:Male  Submitted:2014-04-26, Days after onset: 1
Location:Washington  Entered:2014-04-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4575AA0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH080930IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J0113420PO 
Administered by: Private     Purchased by: Public
Symptoms: Injection site bruising, Injection site induration, Injection site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: R upper thigh with tenderness and bruising and spherical 1 inch subcutaneous firm area, no redness or warmth superficially.

VAERS ID:529410 (history)  Vaccinated:2014-04-15
Age:1.4  Onset:2014-04-21, Days after vaccination: 6
Gender:Male  Submitted:2014-04-25, Days after onset: 4
Location:Kentucky  Entered:2014-04-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Eczema
Diagnostic Lab Data: Patient was prescribed Augmentin 600-42.9 mg/5 mL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4587AA3IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.J01393432IMRL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.K0018540SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH065683IMLL
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Injection site abscess, Nodule, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Patient developed abscess on (R) thigh at injection site about 6 days after vaccine administration. Afebrile in office on 4/22/14 4 x 5 cm erythematous, fluctuant painful nodule noted.

VAERS ID:529419 (history)  Vaccinated:2014-04-22
Age:1.1  Onset:2014-04-23, Days after vaccination: 1
Gender:Male  Submitted:2014-04-25, Days after onset: 2
Location:Alaska  Entered:2014-04-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Patient was seen on 04/23/2014 by PA.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS7C47T0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.J0097142IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H0189450SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH139953IMRL
Administered by: Military     Purchased by: Military
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Child received chicken pox shot on 04/22/2014 and child had small rash 04/23/2014.

VAERS ID:529429 (history)  Vaccinated:2014-04-22
Age:0.6  Onset:2014-04-23, Days after vaccination: 1
Gender:Female  Submitted:2014-04-23, Days after onset: 0
Location:Georgia  Entered:2014-04-25, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Skin rash; formula feeding
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS749CT IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH999AA UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH17300 UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J010966 PO 
Administered by: Private     Purchased by: Public
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Fever and lethargy, not feeling normally. Local area of redness/swelling at injection site.

VAERS ID:529509 (history)  Vaccinated:2014-04-23
Age:0.5  Onset:2014-04-25, Days after vaccination: 2
Gender:Male  Submitted:2014-04-25, Days after onset: 0
Location:Connecticut  Entered:2014-04-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Viral URI
Preexisting Conditions: Eczema
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4660AB2IMLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC200AA2IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH014282IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB415A2PO 
Administered by: Private     Purchased by: Public
Symptoms: Rash, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Had vaccines 4/23. On 4/25 developed hives, facial swelling at 1300 given BENADRYL by EMS. Seen by Dr in clinic at 1430 - had hives on face; no swelling; lacy rash lower abdomen.

VAERS ID:529416 (history)  Vaccinated:2014-04-14
Age:3.0  Onset:2014-04-16, Days after vaccination: 2
Gender:Female  Submitted:2014-04-24, Days after onset: 8
Location:Foreign  Entered:2014-04-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 14-APR-2014, Body temperature, 36.5 Centigrade; Weight, 2844 g
CDC Split Type: 2014110693
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURJ16603SCRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH13E01B3SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dermatitis, Injection site cellulitis, Injection site erythema, Injection site vesicles, Pruritus, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: This is a spontaneous report from a contactable physician through a Company, a vendor company of Pfizer and from regulatory authority. Regulatory authority report number V14000036. A 3 years and 8 months old female patient received fourth dose of PREVENAR 13 (Lot# 13E01B) subcutaneous in left upper arm, on 14Apr2014 at 04:42 pm, at 0.5 ml single and fourth dose of ACT-HIB (Lot# J1660) subcutaneous in right upper arm, on 14Apr2014 at 04:42 pm, at 0.5 ml single. Before the administration, her body temperature was 36.5 Centigrade. The patient''s medical history was not reported. She had a birth weight of 2844 g, had no unusual family history and no precaution for vaccination. Concomitant medications were not reported. On 16Apr2014 at 07:00 pm the patient experienced vaccination site swelling described as swelling from her left upper arm to wrist that was confirmed during bath time. She felt an itching sensation. On 17Apr2014 she visited the reporting physician. Swelling and redness appeared from her left upper arm to wrist. Blister was also confirmed around the needle insertion site applied patch. (The patch had been applied since the administration until hospital visiting. Her right upper arm, which was injected with ACT-HIB, had no swelling). As a result of this clinical course, she had a diagnosis of cellulitis suspected. The reporting physician considered that the symptoms were the side effect of the suspect vaccines, dermatitis was caused by applied patch and cellulitis suspected was infected through the needle insertion site. The reporting physician classified the event as no-serious and assessed it as related to PREVENAR 13. The outcome of the event was unknown.

VAERS ID:529418 (history)  Vaccinated:0000-00-00
Age:0.6  Onset:2014-03-26
Gender:Unknown  Submitted:2014-04-24, Days after onset: 29
Location:Foreign  Entered:2014-04-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Bacterial test, Pneumococcus, ser 10
CDC Split Type: 2014088729
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Meningitis pneumococcal, Streptococcus test positive
SMQs:
Write-up: This is a spontaneous report from contactable physicians received via a Pfizer sales representative. A 7-month-old patient of an unspecified ethnicity and gender received a dose of PREVENAR 13 (lot number unknown) on an unspecified date at 0.5 ml single dose. The patient medical history and concomitant medications were not reported. On 26Mar2014 the patient was observed by a pediatrician at the Hospital who transferred the patient for a central Hospital due to suspicion of meningitis pneumococcal. The patient was currently hospitalized. The patient underwent tests and procedures, which included bacterial test on an unspecified date, identifying Pneumococcus, serotype 10. At the time of the report, the outcome of suspicion of meningitis pneumococcal was unknown. Follow-up (19Apr2014): New information from other two contactable physicians includes: lab data (serotype identification). No follow-up attempts possible. No further information expected.

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